Late Effect of RadiationPhase 3NCT01606644
Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue
A Phase 3 study testing Hyperbaric oxygen in people with Late Effect of Radiation, run by Lone Forner at 1 site in Denmark.
Trial summary
Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue injury to salivary gland tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Late Effect of Radiation
- What is being tested?
- Hyperbaric oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- May 2010to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head and neck cancer with planned radiation therapy
- Age > 18 years
Who cannot join
- Surgical treatment of head and neck cancer
- Salivary gland disease
- Severe claustrophobia
- Pregnancy or lactation (fertile women must use safe contraceptives)
- Uncontrolled hypertension (> 220/110)
- Epilepsy
Show all 12Show fewer
- Lack of ability to equalize inner ear pressure
- Pneumothorax
- Thoracic surgery within one month before HBO treatment
- Abuse of alcohol, drugs or narcotics
- Exposed titanium surfaces or defect titanium in the oral cavity
- Previous HBO treatment
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Anaesthesia and Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital
Copenhagen, DK-2100
Lone Forner, DDS, PhD, +45 3545 8211, lone.forner@rh.regionh.dk
Erik C Jansen, MD. DMSc, +45 3545 1257, erik.jansen@h.regionh.dk
About this study
Official title: Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue.
Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue injury to salivary gland tissue.
- Conditions
- Late Effect of Radiation
- Being tested
- Hyperbaric oxygen
- Keywords
- radiation sequelae, hyperbaric oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenProcedure or surgery
Inhalation of 100% oxygen for 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| HBO | Experimental | 30 90-minute hyperbaric oxygen sessions at 2.4 atm. Receives: Procedure: Hyperbaric oxygen |
| No HBO | No intervention | No intervention. No hyperbaric oxygen is administered. Otherwise, the patient will follow the examination program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivation rate
Measured: 6 months
Secondary outcomes (2)
Quality of life
Measured: 6 months
Xerostomia
Xerostomia questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startMay 2010
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Effect of RadiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lone Forner
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Sponsor-investigator, Lone Forner, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lone Forner, DDS, PhD, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606644
- Sponsor's protocol ID
- HBO Copenhagen study
- Status last verified
- May 2012
- First submitted
- 6 May 2010
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue.
- ClinicalTrials.gov ID
- NCT01606644
- Acronym / sponsor ID
- HBO Copenhagen study
- Conditions
- Late Effect of Radiation
- Keywords
- radiation sequelae, hyperbaric oxygen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lone FornerUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- May 2010
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 28 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue injury to salivary gland tissue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBO | Experimental | Procedure: Hyperbaric oxygen30 90-minute hyperbaric oxygen sessions at 2.4 atm. |
| No HBO | No intervention | –No intervention. No hyperbaric oxygen is administered. Otherwise, the patient will follow the examination program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Head and neck cancer with planned radiation therapy
- Age > 18 years
Key exclusion criteria (12 listed)
- Surgical treatment of head and neck cancer
- Salivary gland disease
- Severe claustrophobia
- Pregnancy or lactation (fertile women must use safe contraceptives)
- Uncontrolled hypertension (> 220/110)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygenInhalation of 100% oxygen for 90 minutes | Procedure or surgery | HBO |
Primary outcome
Salivation rate
Time frame: 6 months
2 secondary outcomes
Quality of life
Time frame: 6 months
Xerostomia
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lone Forner, DDS, PhD principal investigator
Copenhagen University Hospital at Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyperbaric oxygen in people with Late Effect of Radiation, run by Lone Forner at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lone Forner, DDS, PhD (+45 3545 8211, lone.forner@rh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivation rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2012.